Identity
- Trade Name
- Pointe Scientific, Inc. Lipoprotein (a) FDA UDI
- Generic Name
- Lipoprotein A IVD, calibrator FDA UDI
- Device Name
- Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis. FDA UDI
- Model / Reference
- L7597-CAL FDA UDI
- Description
- Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis. FDA UDI
Identifiers
- Catalog Number
- L7597-CAL FDA UDI
- Primary DI / UDI-DI
- 00811727011831 FDA UDI
- 510(k) Number
- K013359 FDA UDI
- FDA Product Code
- DFC FDA UDI
- GMDN Term
- Lipoprotein A IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lipoprotein A IVD, calibrator
Pointe Scientific, Inc. Lipoprotein (a) by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Lipoprotein A IVD, calibrator.
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- Atellica CH Lp(a) Calibrator — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K013359 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI e181712e-fbe3-4304-bdb4-a1b974879489 37 fields · synced Jun 8, 2026